Mindfulness Therapy in Inflammatory Bowel Disease

Bowel Disease Clinical Trial

— Mindfulness  

Official title:

Effects of a Mindfulness Therapy Intervention for Individuals With Inflammatory Bowel Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963246
• Other study ID #: UNIVERSITY CARDENAL HERRERA-4
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: July 2018
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-asusual control group in patients with bowel disease. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Description:

Background: Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms.

Aim: To compare the effects of a specific application of Mindfulness vs. Treatment-as usual control group in patients with bowel disease.

Outcome measures: quality of life, inflammatory and stress markers. Design: randomized controlled trial. Setting: Outpatient setting. Population: patients who attended bimonthly check up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 14, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients with bowel disease diagnostic

• patients with non active disease symptoms in the last 3 month

• patients with access to internet and basic informatic knowledge

Exclusion Criteria:

• active disease symptoms

• planned surgery

• cognitive impairment

• previous experience with mindfulness

Related Conditions & MeSH terms

• Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Mindfulness
Mindfulness-based therapy has been used effectively to treat a variety of physical and psychological disorders, including depression, anxiety, and chronic pain. Recently, several lines of research have explored the potential for mindfulness-therapy in treating somatization disorders, including fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome. Mindfulness-based therapies (MBT) are a clinical application involving the key element of nonjudgmental acceptance of physical pain or psychological distress, thereby reducing the tendency to ruminate over and catastrophise these experiences. In the present study, we propose a mindfulness intervention of 12 months, with sessions either personalized or online.

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Elche

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured with the IBDQ-32 (Inflammatory Bowel Disease Questionnaire)		Change from Baseline IBDQ-32 score at 12 months
Secondary	inflammation stress markers (reactive Protein C and faecal calprotectin)		Change from Baseline inflammation stress markers at 12 months